An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
DFL24498: One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
Vehicle: One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.
Study summary
This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.
Eligibility
Primary outcome measure(s)
- Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye — Baseline to Week 12
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. The CFS is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores five corneal zones from 0 to 3 (total corneal score 0-15) with higher scores indicating more extensive staining.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | Recruiting |
| Canyon City Eyecare | Azusa | California | Recruiting |
| Global Research Management, Inc. | Glendale | California | Recruiting |
| United Medical Research Institute | Inglewood | California | Recruiting |
| LoBue Laser and Eye Medical Center | Murrieta | California | Not Yet Recruiting |
| Eye Research Foundation | Newport Beach | California | Recruiting |
| NVision Clinical Research, LLC | Torrance | California | Recruiting |
| Shettle Eye Research, Inc. | Largo | Florida | Not Yet Recruiting |
| University of South Florida - Marshall Student Center | Tampa | Florida | Not Yet Recruiting |
| Clayton Eye Clinical Research | Morrow | Georgia | Recruiting |
| Price Vision Group / Cornea Research Foundation of America | Indianapolis | Indiana | Recruiting |
| Minnesota Eye Consultants | Minnetonka | Minnesota | Not Yet Recruiting |
| Tekwani Vision Center | St Louis | Missouri | Not Yet Recruiting |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | Not Yet Recruiting |
| Asheville Eye Associates - Regional Medical Park | Asheville | North Carolina | Not Yet Recruiting |
| Oculus Research, Inc. | Garner | North Carolina | Recruiting |
| Core, Inc. | Shelby | North Carolina | Not Yet Recruiting |
| Cincinnati Eye Institute | Mason | Ohio | Not Yet Recruiting |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | Recruiting |
| Total Eye Care, PA - Memphis | Memphis | Tennessee | Recruiting |
| Houston Eye Associates | Houston | Texas | Not Yet Recruiting |
| Lake Travis Eye and Laser Center | Lakeway | Texas | Recruiting |
| Alpine Research Organization, Inc. | Clinton | Utah | Not Yet Recruiting |
| Piedmont Eye Center | Lynchburg | Virginia | Recruiting |
More Dompé Farmaceutici S.p.A trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07503886 on ClinicalTrials.gov ↗ ← All trials in the USA